Initial TV ads for any prescription drug or for a new or expanded approved indication;

All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS); and

TV ads for Schedule II controlled substances.

On May 14, 2012, Pharmaceutical Research and Manufacturers of America (PhRMA) submitted a comment letter to the FDA. In its letter, PhRMA states that the mandatory requirement of review prior to broadcast is “overbroad, unduly burdensome, and lacking in narrow, objective, and definite standards.” According to PhRMA, FDA “is proposing to implement and enforce prior restraint of valuable, constitutionally protected commercial speech.” PhRMA recommends that the FDA undertake “notice and comment rulemaking in a tailored, risk-based approach that conforms with the Supreme Court’s directive that ‘the First Amendment mandates that speech restrictions be narrowly drawn.’”

While the main focus of PhRMA’s comment letter is on the First Amendment’s protection of free speech, PhRMA also discusses the public health value of DTC communications for enhancing public health by conveying information about healthcare treatments to millions of Americans. In addition, PhRMA argues that FDA has not offered evidence to support the need for pre-dissemination review of DTC television advertisements. PhRMA notes that since 2008, “FDA has issued only four warning or untitled letters alleging regulatory violations with respect to DTC television advertisements, despite the fact that hundreds (perhaps thousands) of such ads have been disseminated during that time period.”

Since the proposed guidance makes a substantive change in its regulatory practices, PhRMA contends that FDA should, if at all, implement a formal rulemaking process rather than issuing Guidance for Industry.